Ventilation mask with integrated piloted exhalation valve

ABSTRACT

In accordance with the present invention, there is provided a mask for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilator support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask of the present invention includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. The pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator. The pilot may also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present invention is a continuation-in-part of U.S. patent application Ser. No. 13/411,407 entitled VENTILATION MASK WITH INTEGRATED PILOTED EXHALATION VALVE filed Mar. 2, 2012, which is a continuation of U.S. patent application Ser. No. 13/411,348 entitled VENTILATION MASK WITH INTEGRATED PILOTED EXHALATION VALVE filed Mar. 2, 2012, which claims priority to U.S. Provisional Patent Application Ser. No. 61/499,950 entitled VENTILATION MASK WITH INTEGRATED PILOTED EXHALATION VALVE filed Jun. 22, 2011 and U.S. Provisional Patent Application Ser. No. 61/512,750 entitled VENTILATION MASK WITH INTEGRATED PILOTED EXHALATION VALVE AND METHOD OF VENTILATING A PATIENT USING THE SAME filed Jul. 28, 2011, the disclosures of which are incorporated herein by reference.

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to systems and methods for controlling delivery of a pressurized flow of breathable gas to a patient and, more particularly, to a ventilation mask such as a full face mask, nasal mask, nasal prongs mask or nasal pillows mask for use in critical care ventilation, respiratory insufficiency or OSA (obstructive sleep apnea) with CPAP (Continuous Positive Airway Pressure) therapy and incorporating a piloted exhalation valve inside the mask.

2. Description of the Related Art

As is known in the medical arts, mechanical ventilators comprise medical devices that either perform or supplement breathing for patients. Early ventilators, such as the “iron lung”, created negative pressure around the patient's chest to cause a flow of ambient air through the patient's nose and/or mouth into their lungs. However, the vast majority of contemporary ventilators instead use positive pressure to deliver gas to the patient's lungs via a patient circuit between the ventilator and the patient. The patient circuit typically consists of one or two large bore tubes (e.g., from 22 mm ID for adults to 8 mm ID for pediatric) that interface to the ventilator on one end, and a patient mask on the other end. Most often, the patient mask is not provided as part of the ventilator system, and a wide variety of patient masks can be used with any ventilator. The interfaces between the ventilator, patient circuit and patient masks are standardized as generic conical connectors, the size and shape of which are specified by regulatory bodies (e.g., ISO 5356-1 or similar standards).

Current ventilators are designed to support either “vented” or “leak” circuits, or “non-vented” or “non-leak” circuits. In vented circuits, the mask or patient interface is provided with an intentional leak, usually in the form of a plurality of vent openings. Ventilators using this configuration are most typically used for less acute clinical requirements, such as the treatment of obstructive sleep apnea or respiratory insufficiency. In non-vented circuits, the patient interface is usually not provided with vent openings. Non-vented circuits can have single limb or dual limb patient circuits, and an exhalation valve. Ventilators using non-vented patient circuits are most typically used for critical care applications.

Vented patient circuits are used only to carry gas flow from the ventilator to the patient and patient mask, and require a patient mask with vent openings. When utilizing vented circuits, the patient inspires fresh gas from the patient circuit, and expires CO2-enriched gas, which is purged from the system through the vent openings in the mask. This constant purging of flow through vent openings in the mask when using single-limb circuits provides several disadvantages: 1) it requires the ventilator to provide significantly more flow than the patient requires, adding cost/complexity to the ventilator and requiring larger tubing; 2) the constant flow through the vent openings creates and conducts noise, which has proven to be a significant detriment to patients with sleep apnea that are trying to sleep while wearing the mask; 3) the additional flow coming into proximity of the patient's nose and then exiting the system often causes dryness in the patient, which often drives the need for adding humidification to the system; and 4) patient-expired CO2 flows partially out of the vent holes in the mask and partially into the patient circuit tubing, requiring a minimum flow through the tubing at all times in order to flush the CO2 and minimize the re-breathing of exhaled CO2. To address the problem of undesirable flow of patient-expired CO2 back into the patient circuit tubing, currently known CPAP systems typically have a minimum-required pressure of 4 cmH2O whenever the patient is wearing the mask, which often produces significant discomfort, claustrophobia and/or feeling of suffocation to early CPAP users and leads to a high (approximately 50%) non-compliance rate with CPAP therapy.

When utilizing non-vented dual limb circuits, the patient inspires fresh gas from one limb (the “inspiratory limb”) of the patient circuit and expires CO2-enriched gas from the second limb (the “expiratory limb”) of the patient circuit. Both limbs of the dual limb patient circuit are connected together in a “Y” proximal to the patient to allow a single conical connection to the patient mask. When utilizing non-vented single limb circuits, an expiratory valve is placed along the circuit, usually proximal to the patient. During the inhalation phase, the exhalation valve is closed to the ambient and the patient inspires fresh gas from the single limb of the patient circuit. During the exhalation phase, the patient expires CO2-enriched gas from the exhalation valve that is open to ambient. The single limb and exhalation valve are usually connected to each other and to the patient mask with conical connections.

In the patient circuits described above, the ventilator pressurizes the gas to be delivered to the patient inside the ventilator to the intended patient pressure, and then delivers that pressure to the patient through the patient circuit. Very small pressure drops develop through the patient circuit, typically around 1 cmH2O, due to gas flow though the small amount of resistance created by the tubing. Some ventilators compensate for this small pressure drop either by mathematical algorithms, or by sensing the tubing pressure more proximal to the patient.

Ventilators that utilize a dual limb patient circuit typically include an exhalation valve at the end of the expiratory limb proximal to the ventilator, while ventilators that utilize a single limb, non-vented patient circuit typically include an exhalation valve at the end of the single limb proximal to the patient as indicated above. Exhalation valves can have fixed or adjustable PEEP (positive expiratory end pressure), typically in single limb configurations, or can be controlled by the ventilator. The ventilator controls the exhalation valve, closes it during inspiration, and opens it during exhalation. Less sophisticated ventilators have binary control of the exhalation valve, in that they can control it to be either open or closed. More sophisticated ventilators are able to control the exhalation valve in an analog fashion, allowing them to control the pressure within the patient circuit by incrementally opening or closing the valve. Valves that support this incremental control are referred to as active exhalation valves. In existing ventilation systems, active exhalation valves are most typically implemented physically within the ventilator, and the remaining few ventilation systems with active exhalation valves locate the active exhalation valve within the patient circuit proximal to the patient. Active exhalation valves inside ventilators are typically actuated via an electromagnetic coil in the valve, whereas active exhalation valves in the patient circuit are typically pneumatically piloted from the ventilator through a separate pressure source such a secondary blower, or through a proportional valve modulating the pressure delivered by the main pressure source.

BRIEF SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided a mask (e.g., a nasal pillows mask) for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilatory support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask preferably includes a pressure sensing modality proximal to the patient connection. Such pressure sensing modality may be a pneumatic port with tubing that allows transmission of the patient pressure back to the ventilator for measurement, or may include a transducer within the mask. The pressure sensing port is used in the system to allow pressure sensing for achieving and/or monitoring the therapeutic pressures. Alternately or additionally, the mask may include a flow sensing modality located therewithin for achieving and/or monitoring the therapeutic flows.

The mask of the present invention also includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. In the preferred embodiment, the pilot for the valve is pneumatic and driven from the gas supply tubing from the ventilator. The pilot can also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. In accordance with the present invention, the valve is preferably implemented with a diaphragm.

One of the primary benefits attendant to including the valve inside the mask is that it provides a path for patient-expired CO2 to exit the system without the need for a dual-limb patient circuit, and without the disadvantages associated with a single-limb patient circuit, such as high functional dead space. For instance, in applications treating patients with sleep apnea, having the valve inside the mask allows patients to wear the mask while the treatment pressure is turned off without risk of re-breathing excessive CO2.

Another benefit for having the valve inside the mask is that it allows for a significant reduction in the required flow generated by the ventilator for ventilating the patient since a continuous vented flow for CO2 washout is not required. Lower flow in turn allows for the tubing size to be significantly smaller (e.g., 2-9 mm ID) compared to conventional ventilators (22 mm ID for adults; 8 mm ID for pediatric). However, this configuration requires higher pressures than the patient's therapeutic pressure to be delivered by the ventilator. In this regard, pressure from the ventilator is significantly higher than the patient's therapeutic pressure, though the total pneumatic power delivered is still smaller than that delivered by a low pressure, high flow ventilator used in conjunction with a vented patient circuit and interface. One obvious benefit of smaller tubing is that it provides less bulk for patient and/or caregivers to manage. For today's smallest ventilators, the bulk of the tubing is as significant as the bulk of the ventilator. Another benefit of the smaller tubing is that is allows for more convenient ways of affixing the mask to the patient. For instance, the tubing can go around the patient's ears to hold the mask to the face, instead of requiring straps (typically called “headgear”) to affix the mask to the face. Along these lines, the discomfort, complication, and non-discrete look of the headgear is another significant factor leading to the high non-compliance rate for CPAP therapy. Another benefit to the smaller tubing is that the mask can become smaller because it does not need to interface with the large tubing. Indeed, large masks are another significant factor leading to the high non-compliance rate for CPAP therapy since, in addition to being non-discrete, they often cause claustrophobia. Yet another benefit is that smaller tubing more conveniently routed substantially reduces what is typically referred to as “tube drag” which is the force that the tube applies to the mask, displacing it from the patient's face. This force has to be counterbalanced by headgear tension, and the mask movements must be mitigated with cushion designs that have great compliance. The reduction in tube drag in accordance with the present invention allows for minimal headgear design (virtually none), reduced headgear tension for better patient comfort, and reduced cushion compliance that results in a smaller, more discrete cushion.

The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein. The HME can fully or at least partially replace a humidifier (cold or heated pass-over; active or passive) which may otherwise be included in the ventilation system employing the use of the mask. The HME is positioned within the mask so as to be able to intercept the flow delivered from a flow generator to the patient in order to humidify it, and further to intercept the exhaled flow of the patient in order to capture humidity and heat for the next breath. The HME can also be used as a structural member of the mask, adding q cushioning effect and simplifying the design of the cushion thereof.

The present invention is best understood by reference to the following detailed description when read in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These, as well as other features of the present invention, will become more apparent upon reference to the drawings wherein:

FIG. 1 is top perspective view of a nasal pillows mask constructed in accordance with the present invention and including an integrated diaphragm-based piloted exhalation valve;

FIG. 2 is an exploded view of the nasal pillows mask shown in FIG. 1;

FIG. 3 is a partial cross-sectional view of the nasal pillows mask shown in FIG. 1 taken along lines 3-3 thereof, and depicting the valve pilot lumen extending through the cushion of the mask;

FIG. 4 is a partial cross-sectional view of the nasal pillows mask shown in FIG. 1 taken along lines 4-4 thereof, and depicting the pressure sensing lumen extending through the cushion of the mask;

FIG. 5 is a cross-sectional view of the nasal pillows mask shown in FIG. 1 taken along lines 5-5 thereof;

FIG. 6 is a top perspective view of cushion of the nasal pillows mask shown in FIG. 1;

FIG. 7 is a top perspective view of exhalation valve of the nasal pillows mask shown in FIG. 1;

FIG. 8 is a bottom perspective view of exhalation valve shown in FIG. 7;

FIG. 9 is a cross-sectional view of exhalation valve shown in FIGS. 7 and 8;

FIG. 10 is a cross-sectional view similar to FIG. 5, but depicting a variant of the nasal pillows mask wherein an HME is integrated into the cushion thereof;

FIGS. 11A, 11B and 11C are a series of graphs which provide visual representations corresponding to exemplary performance characteristics of the exhalation valve subassembly of the nasal pillows mask of the present invention;

FIG. 12 is a schematic representation of an exemplary ventilation system wherein a tri-lumen tube is used to facilitate the operative interface between the nasal pillows mask and a flow generating device;

FIG. 13 is a schematic representation of an exemplary ventilation system wherein a bi-lumen tube is used to facilitate the operative interface between the nasal pillows mask and a flow generating device;

FIG. 14 is a side-elevational view of the nasal pillows mask of the present invention depicting an exemplary manner of facilitating the cooperative engagement thereof to a patient through the use of a headgear assembly;

FIG. 15 is a front-elevational view of the nasal pillows mask of the present invention depicting an exemplary tri-lumen tube, Y-connector, and pair of bi-lumen tubes which are used to collectively facilitate the operative interface between the nasal pillows mask and a flow generating device in accordance with the schematic representation shown in FIG. 12;

FIG. 16 is an exploded view of the tri-lumen tube, Y-connector and bi-lumen tubes shown in FIG. 15;

FIG. 17 is a perspective view of the Y-connector shown in FIGS. 15 and 16 in its disconnected state;

FIG. 18 is a side-elevational view of the Y-connector shown in FIGS. 15, 16 and 17 in its disconnected state;

FIG. 19 is a cross-sectional view of one of the identically configured bi-lumen tubes taken along line 19-19 of FIG. 16;

FIG. 20 is a cross-sectional view of the tri-lumen tube taken along line 20-20 of FIG. 16;

FIG. 21 is a cross-sectional view of the tri-lumen tube, Y-connector and bi-lumen tubes shown in FIG. 15 as operatively connected to each other;

FIG. 22 is a cross-sectional view of one of the identically configured bi-lumen tubes shown in FIGS. 15 and 16, but further illustrating in more detail the generally elliptical profile of the gas delivery lumen thereof relative to the generally circular profile of a corresponding connector of the nasal pillows mask which is advanced therein;

FIG. 23 is a cross-sectional view of one of the identically configured bi-lumen tubes which is similar to FIG. 22, but further illustrates the manner in which the receipt of a corresponding, generally circular connector of the nasal pillows mask or Y-connector into the generally elliptical gas delivery lumen facilitates the compression of a portion of the bi-lumen tube as effectively maintains the frictional and airtight engagement thereof with the nasal pillows mask;

FIG. 24 is a perspective view of a segment of a quad-lumen tube which may be used an alternative to the tri-lumen tube shown in FIGS. 15-16 and 19-20; and

FIG. 25 is a cross-sectional view of the quad-lumen tube taken along line 25-25 of FIG. 24;

Common reference numerals are used throughout the drawings and detailed description to indicate like elements.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings wherein the showings are for purposes of illustrating various embodiments of the present invention only, and not for purposes of limiting the same, FIGS. 1-4 depict a ventilation mask 10 (e.g., a nasal pillows mask) constructed in accordance with the present invention. Though the mask 10 is depicted as a nasal pillows mask, those skilled in the art will recognize that other ventilation masks are contemplated herein, such as nasal prongs masks, nasal masks, fill face masks and oronasal masks. As such, for purposes of this application, the term mask and/or ventilation mask is intended to encompass all such mask structures. The mask 10 includes an integrated, diaphragm-implemented, piloted exhalation valve 12, the structural and functional attributes of which will be described in more detail below.

As shown in FIGS. 1-5, the mask 10 comprises a housing or cushion 14. The cushion 14, which is preferably fabricated from a silicone elastomer having a Shore A hardness in the range of from about 20 to 60 and preferably about 40, is formed as a single, unitary component, and is shown individually in FIG. 6. The cushion 14 includes a main body portion 16 which defines a first outer end surface 18 and an opposed second outer end surface 20. The main body portion 16 further defines an interior fluid chamber 22 which is of a prescribed volume. In addition to the main body portion 16, the cushion 14 includes an identically configured pair of hollow pillow portions 24 which protrude from the main body portion 16 in a common direction and in a prescribed spatial relationship relative to each other. More particularly, in the cushion 14, the spacing between the pillow portions 24 is selected to facilitate the general alignment thereof with the nostrils of an adult patient when the mask 10 is worn by such patient. As seen in FIGS. 3 and 4, each of the pillow portions 24 fluidly communicates with the fluid chamber 22.

As shown in FIG. 2, the main body portion 16 of the cushion 14 includes an enlarged, circularly configured valve opening 26 which is in direct fluid communication with the fluid chamber 22. The valve opening 26 is positioned in generally opposed relation to the pillow portions 24 of the cushion 14, and is circumscribed by an annular valve seat 27 also defined by the main body portion 16. As also shown in FIG. 2, the main body portion 16 further defines opposed first and second inner end surfaces 28, 30 which protrude outwardly from the periphery of the valve opening 26, and are diametrically opposed relative thereto so as to be spaced by an interval of approximately 180°. The valve opening 26, valve seat 27, and first and second inner end surfaces 28, 30 are adapted to accommodate the exhalation valve 12 of the mask 10 in a manner which will be described in more detail below.

As shown FIGS. 3-6, the main body portion 16 of the cushion 14 further defines first and second gas delivery lumens 32, 34 which extend from respective ones of the first and second outer end surfaces 18, 20 into fluid communication with the fluid chamber 22. Additionally, a pressure sensing lumen 36 defined by the main body portion extends from the first outer end surface 18 into fluid communication with the fluid chamber 22. The main body portion 16 further defines a valve pilot lumen 38 which extends between the second outer end surface 20 and the second inner end surface 30. The use of the first and second gas delivery lumens 32, 34, the pressure sensing lumen 36, and the valve pilot lumen 38 will also be discussed in more detail below. Those of ordinary skill in the art will recognize that the gas delivery lumens 32, 34, may be substituted with a single gas delivery lumen and/or positioned within the cushion 14 in orientations other than those depicted in FIG. 6. For example, the gas delivery lumen(s) of the cushion 14 may be positioned frontally, pointing upwardly, pointing downwardly, etc. rather than extending laterally as shown in FIG. 6.

Referring now to FIGS. 2-5 and 7-9, the exhalation valve 12 of the mask 10 is made of three (3) parts or components, and more particularly a seat member 40, a cap member 42, and a diaphragm 44 which is operatively captured between the seat and cap members 40, 42. The seat and cap members 40, 42 are each preferably fabricated from a plastic material, with the diaphragm 44 preferably being fabricated from an elastomer having a Shore A hardness in the range of from about 20-40.

As is most easily seen in FIGS. 2, 7 and 9, the seat member 40 includes a tubular, generally cylindrical wall portion 46 which defines a distal, annular outer rim 48 and an opposed annular inner seating surface 49. As shown in FIG. 9, the diameter of the outer rim 48 exceeds that of the seating surface 49. Along these lines, the inner surface of the wall portion 46 is not of a uniform inner diameter, but rather is segregated into first and second inner surface sections which are of differing inner diameters, and separated by an annular shoulder 51. In addition to the wall portion 46, the seat member 40 includes an annular flange portion 50 which protrudes radially from that end of the wall portion 46 opposite the outer rim 48. As shown in FIGS. 2 and 7, the flange portion 50 includes a plurality of exhaust vents 52 which are located about the periphery thereof in a prescribed arrangement and spacing relative to each other. Additionally, as is apparent from FIG. 9, the seat member 40 is formed such that each of the exhaust vents 52 normally fluidly communicates with the bore or fluid conduit defined by the wall portion 46.

The cap member 42 of the exhaust valve 12 comprises a circularly configured base portion 54 which defines an inner surface 56 and an opposed outer surface 58. In addition to the base portion 54, the cap member 42 includes an annular flange portion 60 which circumvents and protrudes generally perpendicularly relative to the inner surface 56 of the base portion 60. The flange portion 60 defines a distal annular shoulder 62. As shown in FIG. 9, the shoulder 62 and inner surface 56 extend along respective ones of a spaced, generally parallel pair of planes. Further, as shown in FIG. 8, formed in the outer surface 58 of the base portion 54 is an elongate groove 64 which extends diametrically across the outer surface 58. The use of the groove 64 will be described in more detail below. The seat and cap members 40, 42, when attached to each other in the fully assembled exhalation valve 12, collectively define an interior valve chamber 59 of the exhalation valve 12. More particularly, such valve chamber 59 is generally located between the inner surface 56 defined by the base portion 54 of the cap member 42 and the seating surface 49 defined by the wall portion 46 of the seat member 40.

The diaphragm 44 of the exhalation valve 12, which resides within the valve chamber 59, has a circularly configured, central body portion 66, and a peripheral flange portion 68 which is integrally connected to and circumvents the body portion 66. The body portion 66 includes an annular lip 72 which circumvents and protrudes upwardly from one side or face thereof. The flange portion 68 includes an arcuately contoured primary region and a distal region which protrudes radially from the primary region. As such, the primary region of the flange portion 68 extends between the distal region thereof and the body portion 66, and defines a continuous, generally concave channel 70.

In the exhalation valve 12, the flange portion 68 of the diaphragm 44 is operatively captured between the flange portions 50, 60 of the seat and cap members 40, 42. More particularly, the annular distal region of the flange portion 68 is compressed (and thus captured) between the shoulder 62 defined by the flange portion 60 of the cap member 42, and a complimentary annular shoulder 53 which is defined by the flange portion 50 of the seat member 40 proximate the exhaust vents 52. The orientation of the diaphragm 44 within the valve chamber 59 when captured between the seat and cap members 40, 42 is such that the channel 70 defined by the arcuately contoured primary region of the flange portion 68 is directed toward or faces the seating surface 49 defined by the wall portion 46 of the seat member 40.

The diaphragm 44 (and hence the exhalation valve 12) is selectively moveable between an open position (shown in FIGS. 3-5 and 9) and a closed position. When in its normal, open position, the diaphragm 44 is in a relaxed, unbiased state. Importantly, in either of its open or closed positions, the diaphragm 44 is not normally seated directly against the inner surface 56 defined by the base portion 54 of the cap member 42. Rather, a gap is normally maintained between the body portion 66 of the diaphragm 44 and the inner surface 56 of the base portion 54. The width of such gap when the diaphragm 44 is in its open position is generally equal to the fixed distance separating the inner surface 56 of the base portion 54 from the shoulder 62 of the flange portion 60. Further, when the diaphragm 44 is in its open position, the body portion 66, and in particular the lip 72 protruding therefrom, is itself disposed in spaced relation to the seating surface 49 defined by the wall portion 46 of the seat member 40. As such, when the diaphragm 44 is in its open position, fluid is able to freely pass through the fluid conduit defined by the wall portion 46, between the seating surface 49 and diaphragm 44, and through the exhaust vents 52 to ambient air. As shown in FIGS. 3, 8 and 9, the flange portion 60 of the cap member 42 is further provided with a pilot port 74 which extends therethrough and, in the fully assembled exhalation valve 12, fluidly communicates with that portion of the valve chamber 59 disposed between the body portion 66 of the diaphragm 44 and the inner surface 56 of the base portion 54. The use of the pilot port 74 will also be described in more detail below.

As will be discussed in more detail below, in the exhalation valve 12, the diaphragm 44 is resiliently deformable from its open position (to which it may be normally biased) to its closed position. An important feature of the present invention is that the diaphragm 44 is normally biased to its open position which provides a failsafe to allow a patient to inhale ambient air through the exhalation valve 12 and exhale ambient air therethrough (via the exhaust vents 52) during any ventilator malfunction or when the mask is worn without the therapy being delivered by the ventilator. When the diaphragm 44 is moved or actuated to its closed position, the lip 72 of the body portion 66 is firmly seated against the seating surface 49 defined by the wall portion 46 of the seat member 40. The seating of the lip 72 against the seating surface 49 effectively blocks fluid communication between the fluid conduit defined by the wall portion 46 and the valve chamber 59 (and hence the exhaust vents 52 which fluidly communicate with the valve chamber 59).

In the mask 10, the cooperative engagement between the exhalation valve 12 and the cushion 14 is facilitated by the advancement of the wall portion 46 of the seat member 40 into the valve opening 26 defined by the cushion 14. As best seen in FIG. 5, such advancement is limited by the ultimate abutment or engagement of a beveled seating surface 76 defined by the flange portion 50 of the seat member 40 against the complimentary valve seat 27 of the cushion 14 circumventing the valve opening 26. Upon the engagement of the seating surface 76 to the valve seat 27, the fluid chamber 22 of the cushion 14 fluidly communicates with the fluid conduit defined by the wall portion 46 of the seat member 40. As will be recognized, if the diaphragm 44 resides in its normal, open position, the fluid chamber 22 is further placed into fluid communication with the valve chamber 59 via the fluid conduit defined by the wall portion 46, neither end of which is blocked or obstructed by virtue of the gap defined between the lip 72 of the diaphragm 44 and the seating surface 49 of the wall portion 46.

When the exhalation valve 12 is operatively coupled to the cushion 14, in addition to the valve seat 27 being seated against the seating surface 76, the first and second inner end surfaces 28, 30 of the cushion 14 are seated against respective, diametrically opposed sections of the flange portion 68 defined by the cap member 42. As best seen in FIGS. 3 and 4, the orientation of the exhalation valve 12 relative to the cushion 14 is such that the end of the valve pilot lumen 38 extending to the second inner end surface 30 is aligned and fluidly communicates with the pilot port 74 within the flange portion 60. As such, in the mask 10, the valve pilot lumen 38 is in continuous, fluid communication with that portion of the valve chamber 59 defined between the inner surface 56 of the base portion 54 and the body portion 66 of the diaphragm 44.

To assist in maintaining the cooperative engagement between the exhalation valve 12 and the cushion 14, the mask 10 is further preferably provided with an elongate frame member 78. The frame member 78 has a generally V-shaped configuration, with a central portion thereof being accommodated by and secured within the complimentary groove 64 formed in the outer surface 58 defined by the base portion 54 of the cap member 42. As shown in FIGS. 3 and 4, the opposed end portions of the frame members 78 are cooperatively engaged to respective ones of the first and second outer end surfaces 18, 20 of the cushion 14. More particularly, as shown in FIG. 2, the frame member 78 includes an identically configured pair of first and second connectors 80, 82 which extend from respective ones of the opposed end portions thereof. The first and second connectors 80, 82 each define opposed inner and outer portions which have generally cylindrical, tubular configurations. The inner portion of the first connector 80 is advanced into and frictionally retained within the first gas delivery lumen 32 of the cushion 14. Similarly, the inner portion of the second connector 82 is advanced into and frictionally retained within the second gas delivery lumen 34 of the cushion 14. As will be described in more detail below, the outer portions of the first and second connectors 80, 82 of the frame member 78 are each adapted to be advanced into and frictionally retained within a corresponding lumen of a respective one of a pair of bi-lumen tubes fluidly coupled to the mask 10.

As shown in FIGS. 3 and 4, the frame member 78 further includes a pressure port 84 which is disposed adjacent the first connector 80. Like each of the first and second connectors 80, 82, the pressure port 84 defines opposed inner and outer portions which each have a generally cylindrical, tubular configuration. The inner portion of the pressure port 84 is aligned and fluidly communicates with the pressure sensing lumen 36 of the cushion 14 subsequent to being advanced and frictionally maintained therein. The frame member 78 is also provided with a pilot port 86 which is disposed adjacent the second connector 82 and also defines opposed inner and outer portions which each have a generally cylindrical, tubular configuration. The inner portion of the pilot port 86 is aligned and fluidly communicates with the valve pilot lumen 38 of the cushion 14 subsequent to being advanced and frictionally maintained therein. As will also be discussed in more detail below, the outer portions of the pressure and pilot ports 84, 86 of the frame member 78 are adapted to be advanced into and frictionally maintained within corresponding lumens of respective ones of the aforementioned pair of bi-lumen tubes which are fluidly connected to the mask 10 within a ventilation system incorporating the same. The receipt of the frame member 78 within the groove 64 of the cap member 42 ensures that the cushion 14, the exhalation valve 12 and the frame member 78 are properly aligned, and prevents relative movement therebetween. Though not shown, it is contemplated that in one potential variation of the mask 10, the cushion 14 may be formed so as not to include the valve pilot lumen 38. Rather, a suitable valve pilot lumen would be formed directly within the frame member 78 so as to extend therein between the pilot port 86 thereof and the pilot port 74 of the exhalation valve 12.

In the mask 10, the exhalation valve 12 is piloted, with the movement of the diaphragm 44 to the closed position described above being facilitated by the introduction of positive fluid pressure into the valve chamber 59. More particularly, it is contemplated that during the inspiratory phase of the breathing cycle of a patient wearing the mask 10, the valve pilot lumen 38 will be pressurized by a pilot line fluidly coupled to the pilot port 86, with pilot pressure being introduced into that portion of the valve chamber 59 normally defined between the body portion 66 of the diaphragm 44 and the inner surface 56 defined by the base portion 54 of the cap member 42 via the pilot port 74 extending through the flange portion 60 of the cap member 42. The fluid pressure level introduced into the aforementioned region of the valve chamber 59 via the pilot port 74 will be sufficient to facilitate the movement of the diaphragm 44 to its closed position described above.

Conversely, during the expiratory phase of the breathing cycle of the patient wearing the mask 10, it is contemplated that the discontinuation or modulation of the fluid pressure through the valve pilot lumen 38 and hence into the aforementioned region of the valve chamber 59 via the pilot port 74, coupled with the resiliency of the diaphragm 44 and/or positive pressure applied to the body portion 66 thereof, will facilitate the movement of the diaphragm 44 back to the open position or to a partially open position. In this regard, positive pressure as may be used to facilitate the movement of the diaphragm 44 to its open position may be provided by air which is exhaled from the patient during the expiratory phase of the breathing circuit and is applied to the body portion 66 via the pillows portions 24 of the cushion 14, the fluid chamber 22, and the fluid conduit defined by the wall portion of the seat member 40. As will be recognized, the movement of the diaphragm 44 to the open position allows the air exhaled from the patient to be vented to ambient air after entering the valve chamber 59 via the exhaust vents 52 within the flange portion 50 of the seat member 40 which, as indicated above, fluidly communicate with the valve chamber 59.

As will be recognized, based on the application of pilot pressure thereto, the diaphragm 44 travels from a fully open position through a partially open position to a fully closed position. In this regard, the diaphragm 44 will be partially open or partially closed during exhalation to maintain desired ventilation therapy. Further, when pilot pressure is discontinued to the diaphragm 44, it moves to an open position wherein the patient can inhale and exhale through the mask 10 with minimal restriction and with minimal carbon dioxide retention therein. This is an important feature of the present invention which allows a patient to wear the mask 10 without ventilation therapy being applied to the mask 10, the aforementioned structural and functional features of the mask 10 making it more comfortable to wear, and further allowing it to be worn without carbon dioxide buildup. This feature is highly advantageous for the treatment of obstructive sleep apnea wherein patients complain of discomfort with ventilation therapy due to mask and pressure discomfort. When it is detected that a patient requires sleep apnea therapy, the ventilation therapy can be started (i.e., in an obstructive sleep apnea situation).

To succinctly summarize the foregoing description of the structural and functional features of the mask 10, during patient inhalation, the valve pilot lumen 38 is pressurized, which causes the diaphragm 44 to close against the seating surface 49, thus effectively isolating the fluid chamber 22 of the mask 10 from the outside ambient air. The entire flow delivered from a flow generator fluidly coupled to the mask 10 is inhaled by the patient, assuming that unintentional leaks at the interface between the cushion 14 and the patient are discarded. This functionality differs from what typically occurs in a conventional CPAP mask, where venting to ambient air is constantly open, and an intentional leak flow is continuously expelled to ambient air. During patient exhalation, the pilot pressure introduced into the valve pilot lumen 38 is controlled so that the exhaled flow from the patient can be exhausted to ambient air through the exhalation valve 12 in the aforementioned manner. In this regard, the pilot pressure is “servoed” so that the position of the diaphragm 44 relative to the seating surface 49 is modulated, hence modulating the resistance of the exhalation valve 12 to the exhaled flow and effectively ensuring that the pressure in the fluid chamber 22 of the mask 10 is maintained at a prescribed therapeutic level throughout the entire length of the exhalation phase. When the valve pilot lumen 38 is not pressurized, the exhalation valve 12 is in a normally open state, with the diaphragm 44 being spaced from the seating surface 49 in the aforementioned manner, thus allowing the patient to spontaneously breathe in and out with minimal pressure drop (also referred to as back-pressure) in the order of less than about 2 cm H2O at 601/min. As a result, the patient can comfortably breathe while wearing the mask 10 and while therapy is not being administered to the patient.

Referring now to FIGS. 11A, 11B and 11C, during use of the mask 10 by a patient, the functionality of the exhalation valve 12 can be characterized with three parameters. These are Pt which is the treatment pressure (i.e., the pressure in the mask 10 used to treat the patient; Pp which is the pilot pressure (i.e., the pressure used to pilot the diaphragm 44 in the exhalation valve 12); and Qv which is vented flow (i.e., flow that is exhausted from inside the exhalation valve 12 to ambient. These three particular parameters are labeled as Pt, Pp and Qv in FIG. 9. When the patient is ventilated, Pt is greater than zero, with the functionality of the exhalation valve 12 being described by the family of curves in the first and second quadrants of FIG. 11A. In this regard, as apparent from FIG. 11A, for any given Pt, it is evident that by increasing the pilot pressure Pp, the exhalation valve 12 will close and the vented flow will decrease. A decrease in the pilot pressure Pp will facilitate the opening of the valve 12, thereby increasing vented flow. The vented flow will increase until the diaphragm 44 touches or contacts the inner surface 56 of the base portion 54 of the cap member 42, and is thus not able to open further. Conversely, when the patient is not ventilated, the inspiratory phase can be described by the third and fourth quadrants. More particularly, Qv is negative and air enters the mask 10 through the valve 12, with the pressure Pt in the mask 10 being less than or equal to zero. Pilot pressure Pp less than zero is not a configuration normally used during ventilation of the patient, but is depicted for a complete description of the functionality of the valve 12. The family of curves shown in FIG. 11A can be described by a parametric equation. Further, the slope and asymptotes of the curves shown in FIG. 11A can be modified by, for example and not by way of limitation, changing the material used to fabricate the diaphragm 44, changing the thickness of the diaphragm 44, changing the area ratio between the pilot side and patient side of the diaphragm 44, changing the clearance between the diaphragm 44 and the seating surface 49, and/or changing the geometry of the exhaust vents 52.

An alternative representation of the functional characteristics of the valve 12 can be described by graphs in which ΔP=Pt−Pp is shown. For example, the graph of FIG. 11B shows that for any given Pt, the vented flow can be modulated by changing ΔP. In this regard, ΔP can be interpreted as the physical position of the diaphragm 44. Since the diaphragm 44 acts like a spring, the equation describing the relative position d of the diaphragm 44 from the seating surface 49 of the seat member 40 is k·d+Pt·At=Pp·Ap, where At is the area of the diaphragm 44 exposed to treatment pressure Pt and Ap is the area of the diaphragm 44 exposed to the pilot pressure Pp. A similar, alternative representation is provided in the graph of FIG. 11C which shows Pt on the x-axis and ΔP as the parameter. In this regard, for any given ΔP, the position d of the diaphragm 44 is determined, with the valve 12 thus being considered as a fixed opening valve. In this scenario Pt can be considered the driving pressure pushing air out of the valve 12, with FIG. 11C further illustrating the highly non-linear behavior of the valve 12.

FIG. 12 provides a schematic representation of an exemplary ventilation system 88 wherein a tri-lumen tube 90 is used to facilitate the fluid communication between the mask 10 and a blower or flow generator 92 of the system 88. As represented in FIG. 12, one end of the tri-lumen tube 90 is fluidly connected to the flow generator 92, with the opposite end thereof being fluidly connected to a Y-connector 94. The three lumens defined by the tri-lumen tube 90 include a gas delivery lumen, a pressure sensing lumen, and a valve pilot lumen. The gas delivery lumen is provided with an inner diameter or ID in the range of from about 2 mm to 15 mm, and preferably about 4 mm to 10 mm. The pressure sensing and valve pilot lumens of the tri-lumen tube 90 are each preferably provided with an ID in the range of from about 0.5 mm to 2 mm. The outer diameter or OD of the tri-lumen tube 90 is preferably less than about 17 mm, with the length thereof in the system 88 being about 1.8 m or 6 ft. The Y-connector 94 effectively bifurcates the tri-lumen tube 90 into the first and second bi-lumen tubes 96, 98, each of which has a length of about 24 inches. The first bi-lumen tube 96 includes a gas delivery lumen having an ID in the range of from about 1 mm to 10 mm, and preferably about 3 mm to 6 mm. The gas delivery lumen of the first bi-lumen tube 96 is fluidly coupled to the outer portion of the first connector 80 of the frame member 78. The remaining lumen of the first bi-lumen tube 96 is a pressure sensing lumen which has an ID in the same range described above in relation to the pressure sensing lumen of the tri-lumen tube 90, and is fluidly coupled to the pressure port 84 of the frame member 78. Similarly, the second bi-lumen tube 98 includes a gas delivery lumen having an ID in the range of from about 1 mm to 10 mm, and preferably about 3 mm to 6 mm. The gas delivery lumen of the second bi-lumen tube 98 is fluidly coupled to the outer portion of the second connector 82 of the frame member 78. The remaining lumen of the second bi-lumen tube 98 is a valve pilot lumen which has an ID in the same range described above in relation to the valve pilot lumen of the tri-lumen tube 90, and is fluidly coupled to the pilot port 86 of the frame member 78.

In the system 88 shown in FIG. 12, the pilot pressure is generated at the flow generator 92. In the prior art, a secondary blower or proportional valve that modulates the pressure from a main blower is used to generate a pressure to drive an expiratory valve. However, in the system 88 shown in FIG. 12, the outlet pressure of the flow generator 92 is used, with the flow generator 92 further being controlled during patient exhalation in order to have the correct pilot pressure for the exhalation valve 12. This allows the system 88 to be inexpensive, not needing additional expensive components such as proportional valves or secondary blowers.

FIG. 13 provides a schematic representation of another exemplary ventilation system 100 wherein a bi-lumen tube 102 is used to facilitate the fluid communication between the mask 10 and the blower or flow generator 92 of the system 100. As represented in FIG. 13, one end of the bi-lumen tube 102 is fluidly connected to the flow generator 92, with the opposite end thereof being fluidly connected to the Y-connector 94. The two lumens defined by the bi-lumen tube 102 include a gas delivery lumen and a pressure sensing lumen. The gas delivery lumen is provided with an inner diameter or ID in the range of from about 2 mm to 10 mm, and preferably about 4 mm to 7 mm. The pressure sensing lumen of the bi-lumen tube 102 is preferably provided with an ID in the range of from about 0.5 mm to 2 mm. The outer diameter or OD of the bi-lumen tube 90 is preferably less than about 11 mm, with the length thereof being about 1.8 m or 6 ft. The Y-connector 94 effectively bifurcates the bi-lumen tube 102 into the first and second bi-lumen tubes 96, 98, each of which has a length of about 24 inches. The first bi-lumen tube 96 includes a gas delivery lumen having an ID in the range of from about 1 mm to 10 mm, and preferably about 3 mm to 6 mm. The gas delivery lumen of the first bi-lumen tube 96 is fluidly coupled to the outer portion of the first connector 80 of the frame member 78. The remaining lumen of the first bi-lumen tube 96 is a pressure sensing lumen which has an ID in the same range described above in relation to the pressure sensing lumen of the bi-lumen tube 102, and is fluidly coupled to the pressure port 84 of the frame member 78. Similarly, the second bi-lumen tube 98 includes a gas delivery lumen having an ID in the range of from about 1 mm to 10 mm, and preferably about 3 mm to 6 mm. The gas delivery lumen of the second bi-lumen tube 98 is fluidly coupled to the outer portion of the second connector 82 of the frame member 78. The remaining lumen of the second bi-lumen tube 98 is a valve pilot lumen which has an ID in the same range described above in relation to the pressure sensing lumen of the bi-lumen tube 102, and is fluidly coupled to the pilot port 86 of the frame member 78.

In the system 100 shown in FIG. 13, the valve pilot lumen 38 is connected to the gas delivery air path at the Y-connector 94. More particularly, the gas delivery lumen of the bi-lumen tube 102 is transitioned at the Y-connector 94 to the valve pilot lumen of the second bi-lumen tube 98. As such, the pilot pressure will be proportional to the outlet pressure of the flow generator 92 minus the pressure drop along the bi-lumen tube 102, which is proportional to delivered flow. This solution is useful when small diameter tubes are used in the system 100, since such small diameter tubes require higher outlet pressure from the flow generator 92 for the same flow. In this regard, since the pressure at the outlet of the flow generator 92 would be excessive for piloting the exhalation valve 12, a lower pressure along the circuit within the system 100 is used. In the system 100, though it is easier to tap in at the Y-connector 94, anywhere along the tube network is acceptable, depending on the pressure level of the flow generator 92 which is the pressure required by the patient circuit in order to deliver the therapeutic pressure and flow at the patient.

In each of the systems 88, 100, it is contemplated that the control of the flow generator 92, and hence the control of therapeutic pressure delivered to the patient wearing the mask 10, may be governed by the data gathered from dual pressure sensors which take measurements at the mask 10 and the output of the flow generator 92. As will be recognized, pressure sensing at the mask 10 is facilitated by the pressure sensing lumen 36 which, as indicated above, is formed within the cushion 14 and fluidly communicates with the fluid chamber 22 thereof. As also previously explained, one of the lumens of the first bi-lumen tube 96 in each of the systems 88, 100 is coupled to the pressure port 84 (and hence the pressure sensing lumen 36). As a result, the first bi-lumen tube 96, Y-connector 94 and one of the tri-lumen or bi-lumen tubes 90, 102 collectively define a continuous pressure sensing fluid path between the mask 10 and a suitable pressure sensing modality located remotely therefrom. A more detailed discussion regarding the use of the dual pressure sensors to govern the delivery of therapeutic pressure to the patient is found in Applicant's co-pending U.S. application Ser. No. 13/411,257 entitled Dual Pressure Sensor Continuous Positive Airway Pressure (CPAP) Therapy filed Mar. 2, 2012, the entire disclosure of which is incorporated herein by reference.

Referring now to FIG. 10, there is shown a mask 10 a which comprises a variant of the mask 10. The sole distinction between the masks 10, 10 a lies in the mask 10 a including a heat and moisture exchanger or HME 104 which is positioned within the fluid chamber 22 of the cushion 14. The HME 104 is operative to partially or completely replace a humidifier (cold or heated pass-over; active or passive) which would otherwise be fluidly coupled to the mask 10 a. This is possible because the average flow through the system envisioned to be used in conjunction with the mask 10 a is about half of a prior art CPAP mask, due to the absence of any intentional leak in such system.

The HME 104 as a result of its positioning within the fluid chamber 22, is able to intercept the flow delivered from the flow generator to the patient in order to humidify it, and is further able to capture humidity and heat from exhaled flow for the next breath. The pressure drop created by the HME 104 during exhalation (back-pressure) must be limited, in the order of less than 5 cmH2O at 601/min, and preferably lower than 2 cmH2O at 601/min. These parameters allow for a low back-pressure when the patient is wearing the mask 10 a and no therapy is delivered to the patient.

It is contemplated that the HME 104 can be permanently assembled to the cushion 14, or may alternatively be removable therefrom and thus washable and/or disposable. In this regard, the HME 104, if removable from within the cushion 14, could be replaced on a prescribed replacement cycle. Additionally, it is contemplated that the HME 104 can be used as an elastic member that adds elasticity to the cushion 14. In this regard, part of the elasticity of the cushion 14 may be attributable to its silicone construction, and further be partly attributable to the compression and deflection of the HME 104 inside the cushion 14.

The integration of the exhalation valve 12 into the cushion 14 and in accordance with the present invention allows lower average flow compared to prior art CPAP masks. As indicated above, normal masks have a set of apertures called “vents” that create a continuous intentional leak during therapy. This intentional leak or vented flow is used to flush out the exhaled carbon dioxide that in conventional CPAP machines, with a standard ISO taper tube connecting the mask to the flow generator or blower, fills the tubing up almost completely with carbon dioxide during exhalation. The carbon dioxide accumulated in the tubing, if not flushed out through the vent flow, would be inhaled by the patient in the next breath, progressively increasing the carbon dioxide content in the inhaled gas at every breath. The structural/functional features of the exhalation valve 12, in conjunction with the use of small inner diameter, high pneumatic resistance tubes in the system in which the mask 10, 10 a is used, ensures that all the exhaled gas goes to ambient. As a result, a vent flow is not needed for flushing any trapped carbon dioxide out of the system. Further, during inspiration the exhalation valve 12 can close, and the flow generator of the system needs to deliver only the patient flow, without the additional overhead of the intentional leak flow. In turn, the need for lower flow rates allows for the use of smaller tubes that have higher pneumatic resistance, without the need for the use of extremely powerful flow generators. The pneumatic power through the system can be kept comparable to those of traditional CPAP machines, though the pressure delivered by the flow generator will be higher and the flow lower.

The reduced average flow through the system in which the mask 10, 10 a is used means that less humidity will be removed from the system, as well as the patient. Conventional CPAP systems have to reintegrate the humidity vented by the intentional leak using a humidifier, with heated humidifiers being the industry standard. Active humidification introduces additional problems such as rain-out in the system tubing, which in turn requires heated tubes, and thus introducing more complexity and cost into the system. The envisioned system of the prent invention, as not having any intentional leak flow, does not need to introduce additional humidity into the system. As indicated above, the HME 104 can be introduced into the cushion 14 of the mask 10 a so that exhaled humidity can be trapped and used to humidify the air for the following breath.

In addition, a big portion of the noise of conventional CPAP systems is noise conducted from the flow generator through the tubing up to the mask and then radiated in the ambient through the vent openings. As previously explained, the system described above is closed to the ambient during inhalation which is the noisiest part of the therapy. The exhaled flow is also lower than the prior art so it can be diffused more efficiently, thus effectively decreasing the average exit speed and minimizing impingement noise of the exhaled flow on bed sheets, pillows, etc.

As also explained above, a patient can breathe spontaneously when the mask is worn and not connected to the flow generator tubing, or when therapy is not administered. In this regard, there will be little back pressure and virtually no carbon dioxide re-breathing, due to the presence of the exhalation valve 12 that is normally open and the inner diameters of the tubes integrated into the system. This enables a zero pressure start wherein the patient falls asleep wearing the mask 10, 10 a wherein the flow generator does not deliver any therapy. Prior art systems can only ramp from about 4 mH2O up to therapy pressure. A zero pressure start is more comfortable to patients that do not tolerate pressure.

As seen in FIG. 14, due to the reduced diameter of the various tubes (i.e., the tri-lumen tube 90 and bi-lumen tubes 96, 98, 102) integrated into the system 88, 100, such tubes can be routed around the patient's ears similar to conventional O2 cannulas. More particularly, the tubing can go around the patient's ears to hold the mask 10, 10 a to the patient's face. This removes the “tube drag” problem described above since the tubes will not pull the mask 10, 10 a away from the face of the patient when he or she moves. As previously explained, “tube drag” typically decreases mask stability on the patient and increases unintentional leak that annoys the patient. In the prior art, head gear tension is used to counter balance the tube drag, which leads to comfort issues. The tube routing of the present invention allows for lower head gear tension and a more comfortable therapy, especially for compliant patients that wear the mask 10 approximately eight hours every night. The reduction in tube drag in accordance with the present invention also allows for minimal headgear design (virtually none), reduced headgear tension for better patient comfort as indicated above, and reduced cushion compliance that results in a smaller, more discrete cushion 14. The tube dangling in front of the patient, also commonly referred to as the “elephant trunk” by patients, is a substantial psychological barrier to getting used to therapy. The tube routing shown in FIG. 14, in addition to making the mask 10, 10 a more stable upon the patient, avoids this barrier as well. Another benefit to the smaller tubing is that the mask 10, 10 a can become smaller because it does not need to interface with large tubing. Indeed, large masks are another significant factor leading to the high non-compliance rate for CPAP therapy since, in addition to being non-discrete, they often cause claustrophobia.

Referring now to FIG. 15, there is shown a front-elevational view of the nasal pillows mask 10, 10 a of the present invention wherein an exemplary tri-lumen tube 90, Y-connector 94, and pair of bi-lumen tubes 96, 98 are used to collectively facilitate the operative interface between the nasal pillows mask 10, 10 a and a flow generating device 92 in accordance with the schematic representation of the ventilation system 88 shown in FIG. 12. As indicated above, in the ventilation system 88, the tri-lumen tube 90 is used to facilitate the fluid communication between the Y-connector 94 and the blower or flow generator 92 of the system 88, with one end of the tri-lumen tube 90 being fluidly connected to the flow generator 92, and the opposite end thereof being fluidly connected to the Y-connector 94.

As is best seen in FIGS. 16, 20 and 21, the tri-lumen tube 90 has a ribbon-like, generally elliptical or oval cross-sectional configuration, and defines three (3) lumens, along with a lengthwise cross-sectional axis A1 and a widthwise cross-sectional axis A2, both of which are shown in FIG. 20. More particularly, the tri-lumen tube 90 includes a gas delivery lumen 104, a pressure sensing lumen 106, and a pilot lumen 108. As best seen in FIG. 20, like the tri-lumen tube 90, the gas delivery lumen 104 has a generally elliptical profile or cross-sectional configuration. Along these lines, the gas delivery lumen 104 is preferably formed so as to have a maximum length L in the range of from about 5 ft. to 10 ft., and preferably about 6 ft.; a maximum width W in the range of from about 8 mm to 13 mm; and a cross-sectional area equivalent to a circular lumen with a diameter of about 2 mm to 15 mm, and preferably about 4 mm to 10 mm, and most preferably about 8 mm. The pressure sensing and pilot lumens 106, 108 are disposed proximate respective ones of the ends of the gas delivery lumen 104 along the axis A1. However, both the pressure sensing and pilot lumens 106, 108 each have a generally circular cross-sectional configuration, as opposed to an elliptical cross-sectional configuration. As is further apparent from FIGS. 16, 20 and 21, the cross-sectional area of the gas delivery lumen 104 substantially exceeds that of each of the pressure sensing and pilot lumens 106, 108, which are preferably identically sized to each other, and are each provided with an inner diameter or ID in the range of from about 0.5 mm to 2 mm. The tri-lumen tube 90 is preferably fabricated from a silicone, TPE or PVC material which has a Shore Hardness in the range of from about 50 A to 80 A, and thus possesses a prescribed level of resilience and flexibility.

The structural features of the tri-lumen tube 90, coupled with the material properties thereof, are selected to not only make it resiliently flexible, but to prevent either of the pressure sensing or pilot lumens 106, 108 from being collapsed by even an above-normal level of bending, twisting or other deflection of the tri-lumen tube 90. In this regard, the elliptical cross-sectional configurations of the tri-lumen tube 90 and its gas delivery lumen 104, coupled with the orientation of the pressure sensing and pilot lumens 106, 108 adjacent respective ones of the opposed ends thereof (along of the lengthwise cross-sectional axis A1), imparts to the tri-lumen tube 90 a tendency to bend in a direction which is generally perpendicular to, rather than aligned with or parallel to the axis A1 (similar to the bending of a ribbon). This manner of bending, which is generally along the axis A2, substantially reduces the susceptibility of the pressure sensing or pilot lumens 106, 108 to inadvertent collapse. Thus, even if the tri-lumen tube 90 is bent beyond that threshold which would typically be encountered during normal use of ventilation system 88 as could result in the collapse or blockage of the gas delivery lumen 104, flow will typically still be maintained through both the pressure sensing and pilot lumens 106, 108. This unobstructed fluid or pneumatic communication through the pressure sensing and pilot lumens 106, 108 provides a modality which, in concert with the control algorithms of the ventilation system 88, may be used to facilitate not only the actuation of the exhalation valve 12 in a manner ensuring unhindered patient breathing through the mask 10, 10 a, but also the sounding of an alarm within the ventilation system 88 and/or adjustment to other operational parameters thereof as are necessary to address the blockage or obstruction of the gas delivery lumen 104.

As indicated above, the structural attributes of the Y-connector 94, which will be described in more detail below, effectively bifurcates the tri-lumen tube 90 into the first and second bi-lumen tubes 96, 98, each of which is of a prescribed length. As best seen in FIGS. 19, 22 and 23, the first and second bi-lumen tubes 96, 98 are identically configured to each other, and each have a generally tear-drop shaped cross-sectional configuration defining an apex 118. The first bi-lumen tube 96 includes a gas delivery lumen 110 and a pressure sensing lumen 112. Similarly, the second bi-lumen to 98 includes a gas delivery lumen 114 and a pilot lumen 116.

In both the first and second bi-lumen tubes 96, 98, the gas delivery lumens 110, 114 each have a generally elliptical cross-sectional configuration or profile, as is most easily seen in FIG. 19. The elliptical cross-sectional area is equivalent to that of a circular lumen having a diameter in the range of from about 1 mm to 10 mm, and preferably about 3 mm to 6 mm, and most preferably about 5 mm. However, the pressure sensing and pilot lumens 112, 116 each have a generally circular cross-sectional configuration or profile, with an inner diameter or ID in the range of from about 0.5 mm to 2 mm. Each bi-lumen tube 96, 98 is preferably fabricated from a silicone, TPE or PVC material which has a Shore Hardness in the range of from about 50 A to 80 A, and thus possesses a prescribed level of resilience and flexibility. The advantages attendant to forming each of the gas delivery lumens 110, 114 of the first and second bi-lumen tubes 96, 98 with a generally elliptical profile will be discussed more detail below.

In the exemplary ventilation system 88, the gas delivery lumen 110 of the first bi-lumen tube 96 is fluidly coupled to the generally cylindrical, tubular outer portion of the first connector 80 of the frame number 78. The pressure sensing lumen 112 of the first bi-lumen tube 96 is itself fluidly coupled to the generally cylindrical, tubular outer portion of the pressure port 84 of the frame number 78 which, as indicated above, is disposed immediately adjacent the outer portion of the first connector 80. As will be recognized, the pressure sensing lumen 112 is sized relative to the outer portion of the pressure port 84 such that the pressure port 84 is frictionally maintained within the first bi-lumen tube 96 once advanced into a corresponding end of the pressure sensing lumen 112 thereof. Similarly, the gas delivery lumen 110 is sized relative to the outer portion of the first connector 80 such that the first connector 80 is frictionally retained within the first bi-lumen tube 96 once advanced into a corresponding end of the gas delivery lumen 110.

Similar to the first bi-lumen tube 96, the gas delivery lumen 114 of the second bi-lumen tube 98 is fluidly coupled to the generally cylindrical, tubular outer portion of the second connector 82 of the frame number 78. The pilot lumen 116 of the second bi-lumen tube 98 is itself fluidly coupled to the generally cylindrical, tubular outer portion of the pilot port 86 of the frame number 78 which, as indicated above, is disposed immediately adjacent the outer portion of the second connector 80. As will be recognized, the pilot lumen 116 is sized relative to the outer portion of the pilot port 86 such that the pilot port 86 is frictionally maintained within the second bi-lumen tube 98 once advanced into a corresponding end of the pilot lumen 116 thereof. Similarly, the gas delivery lumen 114 is sized relative to the outer portion of the second connector 82 such that the second connector 82 is frictionally retained within the second bi-lumen tube 98 once advanced into a corresponding end of the gas delivery lumen 114.

As seen in FIG. 22, whereas the outer portion of each of the first and second connectors 80, 82 has a generally circular cross-sectional configuration, the gas delivery lumens 110, 114 of the first and second bi-lumen tubes 96, 98 each have a generally elliptical cross-sectional configuration or profile as indicated above. In the ventilation system 88, the relative orientations of the outer portions of the first connector 80 and pressure port 84 are the same as those of the outer portions of second connector 82 and pilot port 86. Similarly, the relative orientations of the gas delivery and pressure sensing lumens 110, 112 of the first bi-lumen tube 96 are the same as the gas delivery and pilot lumens 114, 116 of the second bi-lumen tube 98. In the ventilation system 88, these relative orientations are specifically selected so as to achieve a prescribed offset between the axis of the outer portions of the first and second connectors 80, 82 and corresponding ones of the gas delivery lumens 110, 114 when the outer portions of the pressure and pilot ports 80, 82 are coaxially aligned with respective ones of the pressure sensing and pilot lumens 112, 116 of the first and second bi-lumen tubes 96, 98. As a result of these offsets, the advancement of the outer portions of the first and second connectors 80, 82 into corresponding ends of respective ones of the gas delivery lumens 110, 114 facilitates the resilient deformation of each of the first and second bi-lumen tubes 96, 98 in a matter effectively compressing a web portion 120 thereof. As seen in FIGS. 19, 22 and 23, this web portion 120 is disposed between the gas delivery lumen 110, 114 and a corresponding one the pressure sensing and pilot lumens 112, 116. Such compression of the web portion 120 effectively maintains a tight frictional engagement between the first and second bi-lumen tubes 96, 98 and the outer portions of respective ones of the first and second connectors 80, 82 which is less prone to leakage.

The structural features of the first and second bi-lumen tubes 96, 98, coupled with the material properties thereof, are selected to not only to provide resilient flexibility, but to prevent either of the pressure sensing or pilot lumens 112, 116 from being collapsed by even an above-normal level of bending, twisting or other deflection of the corresponding bi-lumen tube 96, 98. In this regard, the elliptical or tear drop shaped cross-sectional configuration of each bi-lumen tube 96, 98, coupled with the orientation of the corresponding pressure sensing or pilot lumen 112, 116 between the gas delivery lumen 110, 114 and the apex 118 thereof, substantially reduces the susceptibility of the pressure sensing or pilot lumens 112, 116 to inadvertent collapse. Thus, even if the first or second bi-lumen tube 96, 98 is bent beyond that threshold which would typically be encountered during normal use of ventilation system 88 as could result in the collapse or blockage of the corresponding gas delivery lumen 110, 114, flow will typically still be maintained through both the pressure sensing and pilot lumens 112, 116. As with the tri-lumen tube 90 described above, this unobstructed flow through the pressure sensing and pilot lumens 112, 116 provides a modality which, in concert with the control algorithms of the ventilation system 88, may be used to facilitate not only the actuation of the exhalation valve 12 in a manner ensuring unhindered patient breathing through the mask 10, 10 a, but also the sounding of an alarm within the ventilation system 88 and/or adjustment to other operational parameters thereof as are necessary to address the blockage or obstruction of either gas delivery lumen 110, 114.

Referring now to FIGS. 15-18 and 21, as indicated above, in the ventilation system 88 the Y-connector 94 facilitates the operative interface between the tri-lumen tube 90 and the first and second bi-lumen tubes 96, 98. More particularly, the Y-connector 94 effectively divides the gas delivery lumen 104 of the tri-lumen tube 90 into the gas delivery lumens 110, 114 of the first and second bi-lumen tubes 96, 98.

Advantageously, the Y-connector 94 is adapted to allow for the selective disconnection or de-coupling of the tri-lumen tube 90 from the first and second bi-lumen tubes 96, 98 without disconnecting or separating either the tri-lumen tube 90 or either of the first and second bi-lumen tubes 96, 98 from the Y-connector 94. In this regard, the Y-connector 94 comprises a male member 118 and a complimentary female member 120 which are releasably engageable to each other. The male member 118 includes a base portion 122 which has a generally elliptical or oval-shaped cross-sectional configuration. In this regard, the cross-sectional length and width dimensions of the base portion 122 along the lengthwise and widthwise major axes thereof are preferably equal or substantially equal to those of the tri-lumen tube 90.

In addition to the base portion 122, the male member 118 includes first and second tube portions 124, 126 which protrude from respective ones of the opposed sides or faces of the base portion 122. Like the base portion 122, the first and second tube portions 124, 126 each have a generally elliptical or oval-shaped cross-sectional configuration. The height of the first tube portion 124 exceeds that of the second tube portion 126. Additionally, the cross-sectional length and width dimensions of the second tube portion 126 are sized so as to slightly exceed those of the gas delivery lumen 104 of the tri-lumen tube 90. Such relative sizing is selected such that the second tube portion 126 may be advanced into yet tightly frictionally maintained within one end of the gas delivery lumen 104. The advancement of the second tube portion 126 into the gas delivery lumen 104 is typically limited by the abutment of the corresponding end of the tri-lumen tube 90 against that end or face of the base portion 122 having the second tube portion 126 protruding therefrom. As will be recognized, due to the maximum cross-sectional length and width dimensions of the base portion 122 preferably being equal or substantially equal to those of the tri-lumen tube 90, the outer surface of the base portion 122 will be substantially flush or continuous with the outer surface of the tri-lumen tube 90 when the corresponding ends are abutted against each other in the aforementioned manner. In the male member 118, the base portion 122 and the first and second tube portions 124, 126 collectively define a gas delivery lumen 128 which is most easily seen in FIG. 21.

The male member 118 further comprises first and second pressure sensing ports 130, 132 which protrude from respective ones of the opposed sides or faces of the base portion 122, and first and second pilot ports 134, 136 which also protrude from respective ones of the opposed sides or faces of the base portion 122. In this regard, the first and second pressure sensing ports 130, 132 are coaxially aligned with each other, as are the first and second pilot ports 134, 136.

In the male member 118, the first pressure sensing and pilot ports 130, 134 are identically configured to each other, with the second pressure sensing and pilot ports 132, 136 being identically configured to each other as well. Though the first and second pressure sensing ports 130, 132 and the first and second pilot ports 134, 136 each have tubular, generally cylindrical configurations with generally circular cross-sectional profiles, the outer diameters of the first pressure sensing and pilot ports 130, 134 exceed those of the second pressure sensing and pilot ports 132, 136. As is best seen in FIG. 21, the first and second pressure sensing ports 130, 132 and the base portion 122 collectively define a pressure sensing lumen 138 of the male member 118. Similarly, the first and second pilot lumens 134, 136 and the base portion 122 collectively define a pilot lumen 140 of the male member 118.

As is most apparent from FIG. 16, the first pressure sensing and pilot ports 130, 134 are oriented so as to be disposed adjacent respective ones of the opposed ends of the first tube portion 124 along the lengthwise cross-sectional axis thereof. Similarly, the second pressure sensing and pilot ports 132, 136 are positioned adjacent respective ones of the opposed ends of the second tube portion 126 along the lengthwise cross-sectional axis thereof. Importantly, the orientation of the second pressure sensing and pilot lumens 132, 136 relative to the second tube portion 126 is such that when the second tube portion 126 is coaxially aligned with the gas delivery lumen 104 of the tri-lumen tube 90, the second pressure sensing and pilot ports 132, 136 will be coaxially aligned with respective ones of the pressure sensing and pilot lumens 106, 108 of the tri-lumen tube 90. As such, when the second tube portion 126 is advanced into the gas delivery lumen 104 in the aforementioned manner, the second sensing port 132 will concurrently be advanced into one end of the pressure sensing lumen 106, with the second pilot port 136 being concurrently advanced into one end of the pilot lumen 108. Along these lines, the outer diameter dimensions of the second pressure sensing and pilot ports 132,136 are preferably sized relative to the inner diameter dimensions of the pressure sensing and pilot lumens 106, 108 such that the second pressure sensing and pilot ports 132, 136 are tightly frictionally retained within respective ones of the pressure sensing and pilot lumens 106, 108 upon being fully advanced therein.

As is best seen in FIGS. 16-18, the male member 118 further includes an opposed, juxtaposed pair of locking tabs 142 which protrude from the base portion 122 and extend along the first tube portion 124. More particularly, the locking tabs 142 are positioned on opposite sides of the first tube portion 124 so as to extend in generally perpendicular relation to the widthwise cross-sectional axis thereof. As will be described in more detail below, the locking tabs 142 are used to facilitate the releasable engagement of the male member 118 to the female member 120. As will also be described in more detail below, the locking tabs 142 may be identically configured to each other, or may alternatively have dissimilar configurations for purposes of insuring that the male and female members 118, 120 are in prescribed orientations relative to each other as a precursor to being releasably engaged to each other.

The female member 120 of the Y-connector 94 comprises a main body portion 144 which itself has a generally elliptical or oval-shaped cross-sectional configuration. In this regard, the cross-sectional length and width dimensions of the body portion 144 along the lengthwise and widthwise major axes thereof are preferably equal or substantially equal to those of the base portion 122 of the male member 118, as well as the tri-lumen tube 90. As best seen in FIGS. 17 and 21, the body portion 144 defines an elongate passage 146 which extends generally axially therein to one of the opposed sides or faces thereof.

In addition to the body portion 144, the female member 120 includes an identically configured pair of first and second gas delivery ports 148, 150 which protrude from a common side or face of the body portion 144, and in particular that side opposite the side having the passage 146 extending thereto. The first and second gas delivery ports 148, 150 each have a tubular, generally cylindrical configuration with a generally circular cross-sectional profile. Additionally, the first and second gas delivery ports 148, 150 each fluidly communicate with one end of the passage 146.

The female member 120 further comprises a pressure sensing port 152 and a pilot port 154 which are identically configured to each other, and protrude from that side or face of the body portion 144 having the first and second gas delivery ports 148, 50 protruding therefrom. More particularly, the pressure sensing port 152 is disposed between the first gas delivery port 148 and one of the opposed ends of the body portion 144 along the lengthwise cross-sectional axis thereof. Similarly, the pilot port 154 is disposed between the second gas delivery port 150 and one of the opposed ends of the body portion 144 along the lengthwise cross-sectional axis thereof. The pressure sensing and pilot ports 152, 154 also each have a tubular, generally cylindrical configuration with a generally circular cross-sectional profile. As is best seen in FIG. 21, the pressure sensing port 152 and the body portion 144 collectively define a pressure sensing lumen 156 of the female member 120. Similarly, the pilot port 154 and the body portion 144 collectively define a pilot lumen 158 of the female member 120.

The first gas delivery port 148 of the female member 120 is adapted to be advanced into one end of the gas delivery lumen 110 of the first bi-lumen tube 96, with the second gas delivery port 150 being adapted for advancement into one end of the gas delivery lumen 114 of the second bi-lumen tube 98. However, whereas the first and second gas delivery ports 148, 150 each have a generally circular cross-sectional configuration, the gas delivery lumens 110, 114 of the first and second bi-lumen tubes 96, 98 each have the generally elliptical cross-sectional configuration or profile as indicated above. In the ventilation system 88, the relative orientations of the first gas delivery port 148 and the pressure sensing port 152 are the same as those of the first connector 80 and pressure port 84 of the mask 10, 10 a. Similarly, the relative orientations of the second gas delivery port 150 and pilot port 154 are the same as those of the second connector 82 and pilot port 86 of the mask 10, 10 a. As with the connection of the first and second bi-lumen tubes 96, 98 to the mask 10, 10 a as explained above, these relative orientations are specifically selected so as to achieve a prescribed offset between the axes of the first and second gas delivery ports 148, 150 and corresponding ones of the gas delivery lumens 110, 114 when the pressure sensing port 152 is coaxially aligned with the pressure sensing lumen 112 of the first bi-lumen tube 96, and the pilot port 154 is coaxially aligned with the pilot lumen 116 of the second bi-lumen tube 98. As a result of these offsets, the advancement of the first and second gas delivery ports 148, 150 into corresponding ends of respective ones of the gas delivery lumens 110, 114 facilitates the resilient deformation of each of the first and second bi-lumen tubes 96, 98 in a manner effectively compressing the web portion 120 thereof. Such compression of the web portion 120 effectively maintains a tight frictional engagement between the first and second bi-lumen tubes 96, 98 and respective ones of the first and second gas delivery ports 148, 150 which is less prone to leakage.

The advancement of the first gas delivery port 148 into the gas delivery lumen 110, as well as the advancement of the second gas delivery port 150 into the gas delivery lumen 114, is limited by the abutment of the corresponding ends of the first and second bi-lumen tubes 96, 98 against that end or face of the body portion 144 having the first and second gas delivery ports 148, 150, as well as the pressure sensing and pilot ports 152, 154, protruding therefrom. As will be recognized, when the first gas delivery port 148 is advanced into the gas delivery lumen 110 in the aforementioned manner, the pressure sensing port 152 is concurrently advanced into one end of the pressure sensing lumen 112. Similarly, when the second gas delivery port 150 is advanced into the gas delivery lumen 114, the pilot port 154 will concurrently be advanced into one end of the pilot lumen 116. Along these lines, the outer diameter dimensions of the pressure sensing and pilot ports 152, 154 are preferably sized relative to the inner diameter dimensions of the pressure sensing and pilot lumens 112, 116 such that the pressure sensing and pilot ports 152, 154 are tightly frictionally retained within respective ones of the pressure sensing and pilot lumens 112, 116 upon being fully advanced therein.

As best seen in FIGS. 16 and 17, the female member 120 further includes an opposed pair of retention tabs 160 which are formed in and extend partially along the body portion 144. More particularly, the retention tabs 160 are positioned on opposite sides of the body portion 144 so as to extend in generally perpendicular relation to the widthwise cross-sectional axis thereof. As will also be described in more detail below, the retention tabs 160 are sized and configured to be releasably engageable to respective ones of the locking tabs 142 to facilitate the releasable engagement of the male member 118 to female member 120. As with the locking tabs 142, the retention tabs 160 may be identically configured to each other, or may alternatively have dissimilar configurations for purposes of ensuring that that the male and female members 118, 120 are in prescribed orientations relative to each other as a precursor to being releasably engaged to each other.

In FIGS. 16-18, the male and female members 118, 120 of the Y-connector 124 are depicted in a disconnected or separated state. When the male member 118 is disconnected from the female member 120, the gas delivery lumens 110, 114 of the first and second bi-lumen tubes 96, 98 each still fluidly communicate with the passage 146 of the female member 120 via respective ones of the first and second gas delivery ports 148, 150. In addition, the pressure sensing lumen 112 of the first bi-lumen tube 96 still fluidly communicates with the pressure sensing lumen 156, with the pilot lumen 116 of the second bi-lumen tube 98 still fluidly communicating with the pilot lumen 158. Further, the gas delivery lumen 128 of the male member 118 still fluidly communicates with the gas delivery lumen 104 of the tri-lumen tube 90 via the second tube portion 126, with the pressure sensing lumen 138 still fluidly communicating with the pressure sensing lumen 106 and the pilot lumen 140 still fluidly communicating with the pilot lumen 108.

The connection of the male and female members 118, 120 to each other is facilitated by initially advancing both the first tube portion 124 and the locking tabs 142 of the male member 118 into the passage 146 of the female member 120 which has a complementary shape adapted to accommodate both the first tube portion 124 and the locking tabs 142. The orientation of the first pressure sensing and pilot ports 130, 134 of the male member 118 relative to the first tube portion 124 is such that the coaxial alignment of the first tube portion 124 with the passage 146 facilitates the concurrent coaxial alignment of the first pressure sensing port 130 with the pressure sensing lumen 156 and the coaxial alignment of the first pressure sensing port 134 with the pilot lumen 158. Along these lines, the full advancement of the first tube portion 124 and locking tabs 142 into the passage 146 results in the concurrent advancement of the first pressure sensing port 130 into the pressure sensing lumen 156, and the first pilot port 134 into the pilot lumen 158. As is best seen in FIG. 21, those end portions of the pressure sensing and pilot lumens 156, 158 extending to the side or face of the body portion 144 having the open end of the passage 146 extending thereto are each slightly enlarged relative to the remainder thereof. These enlarged end portions of the pressure sensing and pilot lumens 156, 158 are adapted to accommodate respective ones of the first pressure sensing and pilot ports 130, 134 which, as indicated above, are slightly larger than corresponding ones of the second pressure sensing and pilot ports 132, 136.

As will be recognized, the full advancement of the first tube portion 124 and locking tabs 142 into the passage 146, and advancement of the first pressure sensing and pilot ports 130, 134 into respective ones of the pressure sensing and pilot lumens 156, 158 is limited by the abutment of that side or face of the body portion 144 of the female member 120 opposite that having the first and second gas delivery ports 148, 150 protruding therefrom against that side or face of the base portion 120 of the male member 118 having the first tube portion 124 protruding therefrom. At the point of such abutment, the locking tabs 142 will releasably engage respective ones of the retention tabs 160 in a manner maintaining the male and female members 118, 120 in releasable engagement to each other.

Each of the retention tabs 160 is sized and configured to be resiliently flexible. Based on the complementary shapes of the locking tabs 142 and retention tabs 160, the application of compressive pressure to each of the retention tabs 160 when the male and female members 118, 120 are cooperatively engaged to each other facilitates the disengagement of the retention tabs 160 from respective ones of the locking tabs 142 as allows for the separation of the male and female members 118, 120 from each other. In the ventilation system 88, it is important that the male and female members 118, 120 not be cross-connected as could result in the pressure sensing lumen 138 of the male member 118 being placed into fluid communication with the pilot lumen 150 of the female member 120, and the pilot lumen 140 of the male member 118 being placed into fluid communication with the pressure sensing lumen 156 of the female member 120. To prevent such occurrence, as indicated above, it is contemplated that the locking tabs 142 and/or the retention tabs 160 of each pair may be provided with dissimilar configurations as ensures that the male and female members 118, 120 can only be releasably connected to each other in one prescribed orientation relative to each other. As will be recognized, such orientation ensures that the pressure sensing lumens 138, 156 are properly placed into fluid communication with each other, as are the pilot lumens 140, 158.

As is best seen in FIG. 21, the full receipt of the first tube portion 124 of the male member 118 into the passage 146 of the female member 120 facilitates the placement of the gas delivery lumen 128 into fluid communication with a segment of the passage 146, as well as each of the first and second gas delivery lumens 148, 150 which each fluidly communicate with the passage 146. Similarly, the complete advancement of the first pressure sensing and pilot ports 130, 134 of the male member 118 into respective ones of the pressure sensing and pilot lumens 156, 158 of the female member 120 effectively places the pressure sensing and pilot lumens 138, 140 of the male member 118 into fluid communication with respective ones of the pressure sensing and pilot lumens 156, 158 of the female member 120. Thus, when the male and female members 118, 120 of the Y-connector 94 are releasably connected to each other in the aforementioned manner, the gas delivery lumen 104 of the tri-lumen tube 90 is effectively bifurcated or divided, and thus placed into fluid communication with the gas delivery lumens 110, 114 of the first and second bi-lumen tubes 96, 98 via the gas delivery lumen 128 of the male member 118, a segment of the passage 146 of the female member 120, and each of the first and second gas delivery ports 148, 150 of the female member 120. In addition, the pressure sensing lumen 106 of the tri-lumen tube 90 is placed into fluid communication with the pressure sensing lumen 112 of the first bi-lumen tube 96 by the pressure sensing lumen 138 of the male member 118 and the pressure sensing lumen 156 of the female member 120. Similarly, the pilot lumen 108 of the tri-lumen tube 90 is placed into fluid communication with the pilot lumen 116 of the second bi-lumen tube 98 via the pilot lumen 140 of the male member 118 and the pilot lumen 158 of the female member 120. Though not shown with particularity in FIGS. 16-18 and 21, it is contemplated that the Y-connector 94, and in particular the male and female members 118, 120 thereof, may be outfitted with sealing members such as O-rings as needed to facilitate the formation of fluid-tight seals between the same when releasably connected to each other.

Referring now to FIGS. 24 and 25, there is depicted a portion of a quad-lumen tube 190 which may be integrated into the ventilation system 88 as an alternative to the above-described tri-lumen tube 90. The quad-lumen tube 190 has a generally circular, cross-sectional configuration, and defines four (4) lumens. More particularly, the quad-lumen tube 190 includes a gas delivery lumen 194, a pressure sensing lumen 196, a pilot lumen 198, and an auxiliary lumen 200. The pressure sensing, pilot and auxiliary lumens 196, 198, 200 are preferably disposed about the gas delivery lumen 194 in equidistantly spaced intervals of approximately 120°, and have identically dimensioned, generally circular cross-sectional configurations.

As is apparent from FIGS. 24 and 25, the cross-sectional configuration of the quad-lumen tube 190 is not uniform along the entire length thereof. Rather, each of the opposed end portions of the quad-lumen tube 190 (one of which is shown in FIG. 24) have cross-sectional configurations differing from that the central section or portion of the quad-lumen tube 190 extending between such end portions. More particularly, as seen in FIG. 25, the gas delivery lumen 194 defined by the central portion of the quad-lumen tube 190 extending between the end portions thereof does not have a generally circular cross-sectional configuration. Rather, portions of the quad-lumen tube 90 which accommodate respective ones of the pressure sensing, pilot and auxiliary lumens 196, 198, 200 protrude into the gas delivery lumen 194, thus imparting a generally cloverleaf cross-sectional configuration thereto. In contrast, at each of the opposed end portions of the quad-lumen tube 190, those portions of the quad-lumen tube 190 accommodating respective ones of the pressure sensing, pilot and auxiliary lumens 196, 198, 200 transition to the exterior of the gas delivery lumen 194, thus resulting in such gas delivery lumen 194 assuming a generally circular cross-sectional configuration. Those of ordinary skill in the art will recognize that the quad-lumen tube 190 may be formed so as not to include the aforementioned alternatively configured end portions, the non-circular cross-sectional configuration of the central portion of the gas delivery lumen 194 thus being consistent throughout the entire length of the quad-lumen tube 190. However, if the alternatively configured end portions are provided, it is contemplated that they may be formed through the implementation of a specialized extrusion process, or as separate parts which are glued or molded onto the aforementioned central portion of the quad-lumen tube 190. In the quad-lumen tube 190, it is also contemplated that the inner diameters of each of the pressure sensing, pilot and auxiliary lumens 196, 198, 200 will be similar to those of the pressure sensing and pilot lumens 106, 108 of the tri-lumen tube 90 as described above, with the cross-sectional area of the gas delivery lumen 194 being similar to that of the gas delivery lumen 104 of the tri-lumen tube 90 as also described above.

As will be recognized by those of ordinary skill in the art, providing the gas delivery lumen 194 with a generally circular cross-sectional configuration or profile at each of the opposed end portions of the quad-lumen tube 190 makes it easier to couple or operatively interface the quad-lumen tube 190 to a Y-connector at one end thereof, and to a flow generator at the opposite end thereof. Along these lines, the circularly configured end portions of the gas delivery lumen 194 are more easily advanced over and frictionally retained upon a cylindrically configured port, as opposed to a port that would otherwise need to be provided in a non-standard configuration so as to be capable of advancement into the gas delivery lumen 194 having the shape shown in FIG. 25. In the quad-lumen tube 190, the auxiliary lumen 200 may be used, for example, to route optical fibers or wires as could potentially be used to illuminate the Y-connector. Assuming such Y-connector has a two-piece, detachable construction as described above in relation to the Y-connector 94, the illumination thereof would provide greater ease to a patient to effectuate the disconnection of the male and female members from each other at night, in darkness.

The quad-lumen tube 190 is preferably fabricated from a silicone, TPE or PVC material which has a Shore Hardness in the range of from about 50 A to about 80 A, and thus possesses a prescribed level of resilience and flexibility. Further, as seen in FIG. 24, it is contemplated that the wall of the quad-lumen tube 190 defining or partially defining the gas delivery lumen 194 will have a spiral-shaped reinforcement ribbon 202 embedded therein. It is contemplated that such ribbon 202 will extend along the central portion of the quad-lumen tube 190, but not into either of the alternatively configured end portions thereof. The ribbon 202 enhances the structural integrity of the quad-lumen tube 190, thus making the gas delivery, pressure sensing and pilot lumens 194, 196, 198 less susceptible to collapse upon any excessive bending or compression of the quad-lumen tube 190. It is also contemplated that the ribbon 202 could be substituted with a reinforcement braiding which is adapted to enhance the structural integrity of the quad-lumen tube 190 in the aforementioned manner. However, those or ordinary skill in the art will recognize that the quad-lumen tube 190 need necessarily have the ribbon 202 or other type of reinforcement braiding integrated therein. Along these lines, it is also contemplated that the quad-lumen tube 190 could further be alternatively configured such that the pressure sensing, pilot and auxiliary lumens 196, 198, 200 assume a generally helical profile along the length thereof, thus mimicking the effect of the effect of the ribbon 202, and assisting in the prevention of the kinking or collapse of the quad-lumen tube 190. Also, though not shown, it is contemplated that a reinforcement ribbon similar to the ribbon 202 or reinforcement braiding may be integrated into the above-described tri-lumen tube 90.

This disclosure provides exemplary embodiments of the present invention. The scope of the present invention is not limited by these exemplary embodiments. Numerous variations, whether explicitly provided for by the specification or implied by the specification, such as variations in structure, dimension, type of material and manufacturing process may be implemented by one of skill in the art in view of this disclosure. 

What is claimed is:
 1. A respiratory assistance system, comprising: a flow generator; a nasal pillows mask; and a fluid conduit fluidly coupling the flow generator to the nasal pillows mask, and comprising: a tri-lumen tube which has a generally elliptical, oval-shaped cross-sectional configuration, and is fluidly coupled to the flow generator; a first bi-lumen tube which has a generally teardrop-shaped cross-sectional configuration, and is fluidly coupled to and extends between the tri-lumen tube and the nasal pillows mask; and a second bi-lumen tube which has a generally teardrop-shaped cross-sectional configuration, and is fluidly coupled to and extends between the tri-lumen tube and the nasal pillows mask.
 2. The respiratory assistance system of claim 1 wherein: the tri-lumen tube defines a gas delivery lumen, a valve pilot lumen and a pressure sensing lumen which are each fluidly coupled to the flow generator; the first bi-lumen tube defines a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the tri-lumen tube and the nasal pillows mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the tri-lumen tube and the nasal pillows mask; and the second bi-lumen tube defines a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the tri-lumen tube and the nasal pillows mask, and a valve pilot lumen which is fluidly coupled to and extends between the valve pilot lumen of the tri-lumen tube and the nasal pillows mask.
 3. The respiratory assistance system of claim 2 further comprising: a Y-connector which is fluidly coupled to the tri-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the tri-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, facilitate the fluid coupling of the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube to each other; the Y-connector including at least first and second members which are releasably connectable to each other as allows for the selective detachment and separation of the tri-lumen tube from each of the first and second bi-lumen tubes.
 4. The respiratory assistance system of claim 3 wherein: the Y-connector comprises male and female members; the male member of the Y-connector is fluidly coupled to the tri-lumen tube; the female member of the Y-connector is fluidly coupled to each of the first and second bi-lumen tubes; and the male and female members are configured so as to be releasably attachable to each other only in a manner wherein the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube are placed into fluid communication with each other.
 5. The respiratory assistance system of claim 2 wherein the gas delivery lumen of the tri-lumen tube has a generally elliptical, oval shaped cross-sectional configuration, and each of the pressure sensing and valve pilot lumens thereof has a generally circular cross-sectional configuration.
 6. The respiratory assistance system of claim 2 wherein: the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; the pressure sensing and valve pilot lumens of respective ones of the first and second bi-lumen tubes each have a generally circular cross-sectional configuration; and the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.
 7. The respiratory assistance system of claim 6 wherein the nasal pillows mask comprises: a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration; a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration; the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes.
 8. The respiratory assistance system of claim 7 wherein: the relative orientations of the gas delivery and pressure sensing lumens of the first bi-lumen tube are the same as those of the gas delivery and pilot lumens of the second bi-lumen tube; and the relative orientations of the first connector and the pressure port are the same as those of the second connector and the pilot port.
 9. A respiratory assistance system, comprising: a flow generator; a nasal pillows mask; and a fluid conduit fluidly coupling the flow generator to the nasal pillows mask, and comprising: a tri-lumen tube which defines a gas delivery lumen, a valve pilot lumen and a pressure sensing lumen which are each fluidly coupled to the flow generator; a first bi-lumen tube which defines a gas delivery lumen and a pressure sensing lumen which are each fluidly coupled to the nasal pillows mask; and a second bi-lumen tube which defines a gas delivery lumen and a pilot lumen which are each fluidly coupled to the nasal pillows mask; and a Y-connector which is fluidly coupled to the tri-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the tri-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, facilitate the fluid coupling of the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube to each other; the Y-connector including at least first and second members which are releasably connectable to each other as allows for the selective detachment and separation of the tri-lumen tube from each of the first and second bi-lumen tubes.
 10. The respiratory assistance system of claim 9 wherein: the Y-connector comprises male and female members; the male member of the Y-connector is fluidly coupled to the tri-lumen tube; the female member of the Y-connector is fluidly coupled to each of the first and second bi-lumen tubes; and the male and female members are configured so as to be releasably attachable to each other only in a manner wherein the pressure sensing lumens of the tri-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the tri-lumen tube and the second bi-lumen tube are placed into fluid communication with each other.
 11. The respiratory assistance system of claim 9 wherein: the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; and the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.
 12. The respiratory assistance system of claim 11 wherein the nasal pillows mask comprises: a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration; a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration; the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes.
 13. The respiratory assistance system of claim 12 wherein: the relative orientations of the gas delivery and pressure sensing lumens of the first bi-lumen tube are the same as those of the gas delivery and pilot lumens of the second bi-lumen tube; and the relative orientations of the first connector and the pressure port are the same as those of the second connector and the pilot port.
 14. A respiratory assistance system, comprising: a flow generator; a nasal pillows mask; and a fluid conduit fluidly coupling the flow generator to the nasal pillows mask, and comprising: a quad-lumen tube which is fluidly coupled to the flow generator and defines a gas delivery lumen, a valve pilot lumen, a pressure sensing lumen and an auxiliary lumen; a first bi-lumen tube which defines a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the tri-lumen tube and the nasal pillows mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the tri-lumen tube and the nasal pillows mask; and a second bi-lumen tube which defines a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the tri-lumen tube and the nasal pillows mask, and a valve pilot lumen which is fluidly coupled to and extends between the valve pilot lumen of the tri-lumen tube and the nasal pillows mask.
 15. The respiratory assistance system of claim 14 further comprising: a Y-connector which is fluidly coupled to the quad-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the quad-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, facilitate the fluid coupling of the pressure sensing lumens of the quad-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the quad-lumen tube and the second bi-lumen tube to each other.
 16. The respiratory assistance system of claim 14 wherein the gas delivery lumen of the quad-lumen tube includes a central portion which has a generally cloverleaf cross-sectional configuration, and an opposed pair of end portions which each have a generally circular cross-sectional configuration.
 17. The respiratory assistance system of claim 16 wherein the valve pilot, pressure sensing and auxiliary lumens of the quad-lumen tube are separated from each other by intervals of approximately 120°, and each have a generally circular cross-sectional configuration.
 18. The respiratory assistance system of claim 16 wherein the quad-lumen tube includes a reinforcement ribbon which is embedded therein and extends along at least the central portion of the gas delivery lumen thereof.
 19. The respiratory assistance system of claim 14 wherein: the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; and the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.
 20. The respiratory assistance system of claim 19 wherein the nasal pillows mask comprises: a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration; a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration; the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes. 